Sterile Drug Manufacturing with Revised EU GMP Annex 1 and USP <382>

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The revised EU GMP Annex 1 underscores the need for a holistic contamination control strategy (CCS) in sterile drug manufacturing. A robust CCS requires both individual and collective effectiveness, ensuring contamination risks are identified, mitigated, and controlled across the supply chain. This webinar will provide an overview of how pharmaceutical manufacturers and component suppliers can align to help the pharmaceutical manufacturer meet the Annex 1 expectations.

Building a “living” strategy—one that evolves with regulatory updates—demands a strong quality culture, knowledge management, and a community of practice. We will explore how West has empowered teams to work with an Annex 1 mindset to help customers build their compliance while fostering collective and continuous improvements in contamination control.

In addition to Annex 1, this session will cover the impact of USP <382>, which comes into effect December 1st, 2025, and establishes new qualification standards for elastomeric components used in injectable drug packaging. USP <382> introduces more stringent requirements for functionality, physicochemical properties, and biocompatibility, aiming to enhance patient safety and product integrity. We will discuss key considerations for pharmaceutical manufacturers, and the role of suppliers in ensuring compliance. Topics will include extractables and leachables testing, material compatibility, performance testing, and risk assessment strategies.

By integrating both Annex 1 and USP <382> into contamination control efforts, companies can strengthen their risk mitigation strategies while ensuring regulatory alignment. Join us to gain valuable insights into best practices, and proactive approaches for building a robust and future-ready CCS.

Dr. Ana Kuschel, Principal Scientific Affairs Europe

Ana Kuschel

Principal Scientific Affairs, West Pharmaceutical Services

As Principal Scientific Affairs Europe, Ana is providing technical support relating to West’s packaging components and delivery systems for injectable drugs and healthcare products. As well as bridging scientific information through industry outreach. This is complementing her previous role as Manager Material Development, where she worked on both existing and new rubber formulations. Ana holds a PhD in macromolecular chemistry and is an active member of the ISO TC 76 and PDA Packaging Science groups.
Speaker- Todd Jasinski

Todd Jasinski

Senior Specialist, Technical Product Development

After graduating from the University of Pittsburgh with a degree in Mechanical Engineering and minor in Bioengineering, Todd worked as a design engineer at two medical device companies in the spinal implantation and fusion industry. After innovating, developing, and launching multiple implants to improve patient outcomes, he joined West Pharmaceutical Services as a Senior Specialist in the Technical Product Development department. His primary focus has been elastomeric closures and the required testing to prove closure functional performance. The evolution of the compendial landscape, such as USP <382>, has led to his involvement in understanding the standards to ensure West products meet and exceed industry requirements.